Ventricular fibrillation (VF) is a lethal cardiac arrhythmia for which the only known efficacious treatment is electrical countershock. A victim of VF outside of the hospital setting has little chance of survival since treatment must take place within a few minutes after the onset of the episode.
Fortunately, new techniques and devices are being devised to help deal with this life threatening condition. Among these are computer techniques which aid in the identification of high risk VF patients, anti-arrhythmic drugs which can prophylactically be administered to these patients, programs for wide-spread cardiopulmonary resuscitation training, and implantable devices which can automatically detect VF and deliver cardioverting countershocks.
"Cardioverting" or "cardioversion" as used herein is intended to encompass the correction of a number of arrhythmic heat conditions, both lethal and non-lethal. Those arrhythmic heart conditions include atrial tachycardia, atrial flutter, atrial fibrillation, junctional rhythms, ventricular tachycardia, ventricular flutter, ventricular fibrillation, and any other non-pacemaking related arrhythmic condition which may be corrected by applying electrical shocks to the heart. Obviously then, "defibrillation" is included in the term cardioversion as a method of applying electrical shocks to the heart to defibrillate fibrillating atria or fibrillating ventricles.
Many of the known techniques, such as defibrillation in a hospital setting or defibrillation by a paramedic as part of a resuscitation program, rely upon the human detection of VF. This detection has typically been accomplished by a trained operator interpreting an ECG from an oscilloscope tracing. However, there are situations where such an approach to reversing VF is impossible or impractical. There is accordingly a great need for an electronic device able to accurately detect VF or other life threatening arrhythmias from an input ECG where such a traditional approach is unfeasible. For example, an external defibrillator could be built with an interlock to its discharge switch so that a shock can be delivered only after the presence of VF has been confirmed by a detector receiving an ECG signal from the paddles. Such a defibrillator could safely be used by even an untrained operator.
With regard to the automatic implantable defibrillator, techniques have been developed which are generally acceptable for detecting VF and discriminating between life threatening arrhythmias and other cardiac malfunctions. Yet there is considerable room for improvement with regard to detecting and discriminating VF from other non-fatal arrhythmias. Accordingly, another use for such a detector, as noted above, would be in the fully-implantable automatic defibrillator.
Previous approaches to VF detection for implantable devices have had certain drawbacks. Fundamental questions, particularly important to an automatic implantable defibrillator, relate to potential failure modes, the risks to a patient should the device reach one of these failure modes, and specifically to whether failure should occur in a passive or an active manner. Considerations of failure modes in another field, for example, have led pacer manufacturers to design pacers to resort to fixed rate pacing, an active mode, should there be a sensing failure such as caused by interference. The risk of competing with the natural heartbeat has been judged less than the risk of potential inhibition when pacing is needed.
Similar principles apply to the automatic implantable defibrillator, though simple answers do not exist. An active mode failure would result in the delivery of a shock when none is necessary, an occurrence which could be particularly unpleasant to the patient. A passive mode failure, on the other hand, would inhibit the delivery of a necessary shock, and could result in death. Obviously, failures must be minimized, but they still must be considered. In this regard, it is believed preferable that potential sensing failures lead to inherent passivity of a defibrillating device.
In many known VF detectors and automatic implantable defibrillators, the primary detection schemes would result in active mode failures unless other lock-out circuitry is provided. Examples are R-wave sensors, pressure sensors, and elastomeric contraction sensors. In each case a failure in the primary sensor would have the same inherent effect as fibrillation, causing the automatic implantable device to fire, an active failure.
There is accordingly a great need for a VF detector which is accurate in its detection of VF or other life threatening arrhythmias, so that failure modes may be passive. It is toward the development of a VF detector such as this that the present invention is directed. The present invention is directed more generally to the development of an accurate, simple detector of cardiac arrhythmias which overcomes or eliminates the drawbacks of known detectors.